Over the last 30 years, 20 per cent of drugs approved by the FDA were later classified as “BAD Drugs”, meaning that they were later withdrawn from the market or given a black box warning.(1)(2) Why does the FDA approve risky drugs which end up being banned? This question is explored by Daryl Kulakin on his That's Fit Blog detailing conflicts of interest in medicine and corruption in medical journals.(3) This issue is also explored by Shannon Brownlee in her Washington Monthly article, "why you can’t trust medical journals anymore".(4)

Image left: Lawyers by Daumier, Honoré B.1808 courtesy of wikipedia.

The FDA Can't Protect You From Bad Drugs

David Graham MD, Director of Drug Safety at the FDA uttered his famous phrase during Congressional testimony November 2004 “The FDA is incapable of protecting the American Public against another Vioxx”.(5)(6)(7)(8)

How can you determine if you are dealing with a BAD DRUG?

Here are the early warning signs:

1) The drug has been recalled or given a black box warning.

2) The drug is in litigation with numerous lawsuits against the drug company.

3) The drug has been banned in other countries.

Listing of Drugs which have black box warnings:

This lengthy list involves literally hundreds of drugs, so Click Here for the list.(9)

Do you like lawyers? If you asked me if I liked lawyers, I would laugh and tell you a few lawyer jokes. One of my favorites is, “How do you tell the difference between a lawyer and a sperm? The answer is: the sperm has a one in 10 million chance of becoming a human being”. In spite of the jokes, and since the FDA can't protect us, lawyers and drug litigation may be our last protection from bad drugs. Drug litigation by lawyers gives us an early warning sign about a bad drug. Drug litigation can uncover secret information about adverse drug side effects which drug companies hide from the public (13).

Avandia (rosiglitazone) by GlaxoSmithKline, is used for adult onset Type 2 diabetes. (thiazolidinedione class of drugs). Avandia causes a 43% higher risk of heart attacks. This is ironic because diabetes causes accelerated heart disease, and controlling diabetes with drugs is supposed to reduce incidence of heart attacks, not increase it. (15)(16)

Rezulin was used for blood sugar control in patients with adult onset type 2 diabetes. Rezulin has been recalled due to liver toxicity.

Zelnorm for Constipation - Banned

Zelnorm (tegaserod) was FDA approved for irritable bowel syndrome and constipation in women. Novartis agreed to voluntarily suspend sales of Zelnorm March 2007, following reports of adverse side effects such as heart attack and stroke. They then withdrew Zelnorm from the market.

Permax and Dostinex

Permax (pergolide) and Dostinex (cabergoline) are used for Parkinson's, restless leg syndrome, and migraine headaches. Other similar drugs have been banned such as the diet drug Fen-phen. Thy are all associated with heart valve problems and leaky valves. Permax currently has a black box warning about this increased risk of heart valve problems. The sale of Permax has been suspended by Valeant.(17)

As of May 13, 2007, hundreds of lawsuits had been filed against Merck alleging Fosamax-induced Necrosis of the Jaw, (ONJ)The first case is set to be tried in late 2008 in New York. (19)

Fosamax is Merck's bisphosphonate osteoporosis drug which causes osteonecrosis ONJ of the jaw, an irreversible breakdown of the jawbone, associated with ulcerations in the mouth, non-healing wounds, and osteomyelitis of the jaw. (19A) (20) (21) (22) (23)

Warnings have been sent out to all dentists and endodontists: This is the (Endodontists) AAE Position Statement: "Endodontic Implications of Bisphosphonate-Associated Osteonecrosis of the Jaws American Endodontists Association" (24).

The osteoporosis drugs are supposed to make the bones stronger. Again, it is ironic that these drugs cause the jaw bone to literally fall apart, meaning they make the bones weaker, not stronger. I predict this entire class of bisphosphonate drugs will eventually be banned. For more information on these drugs, see my articles on the bisphosphonate drugs.(52)(53)

Synthetic Hormones

Prempro manufactured by Wyeth (25) is a hormone replacement pill containing Premarin and Provera, synthetic female hormones. Premarin is horse estrogen from a pregnant horse. Provera is a synthetic progesterone which is chemically altered and is not normally present in the human body or anywhere else in nature.

The large, NIH funded, (WHI) Women’s Health Initiative Study was terminated early when its data showed that Prempro increased risk of Heart Disease and Breast Cancer (26) (27). Bio-Idential Human Hormones, on the other hand, are NOT associated with increased risk of cancer or heart disease, this increased risk applies ony to the synthetic hormones not found in the human body such as Prempro.

Ortho Evra

Ortho Evra (birth control / contraceptive skin patch) by Ortho-McNeil Pharmaceuticals contains synthetic hormones, norelgestromin and ethinyl estradiol, delivered in a transdermal birth control patch. In November 2005, the FDA warned that the product contains higher levels of estrogen than most others and increases risk of blood clots, strokes, and heart attacks.

Depo-Provera

Depo-Provera is a a synthetic hormone used for birth control, injected every 3 months. Long term use causes osteoporosis, fractures, spine injuries and hip injuries. A $700 million class action lawsuit was filed against Pfizer in Toronto on behalf of Canadian women aged 38 to 32 who used Depo-Provera and developed osteoporosis. Several lawsuits making the same allegations against Pfizer have been filed in the United States.

Vioxx, Celebrex, Bextra, Cox-2 inhibitor Pain Pills

Vioxx (rofecoxib) by Merck is a pain medication causing adverse reactions such as heart attack, stroke, and sudden cardiac death. In September 2004, Merck voluntarily withdrew Vioxx from the market. Dr. David Graham, Director of Drug Safety at the FDA, said that Vioxx caused up to 160,000 heart attacks and strokes. (44)(45) Forty Five Thousand people have sued Merck, and Merk has spent 1 billion on legal fees. Merck’s strategy is to fight every case by bringing it to trial and drag out the proceedings. On November 9, 2007, Merck agreed to pay $4.85 billion to settle all of the court claims.(51)

Celebrex: A Cox-2 inhibitor approved for the treatment of rheumatoid arthritis and osteoarthritis, and later approved for familial polyposis (colon polyps) . Celebrex may increase the risk of heart attack or stroke.

Bextra (valdecoxib) by Pfizer is similar to Vioxx. Studies have shown adverse reactions with Bextra such as heart attack, stroke, sudden cardiac death, Erythema Multiforme (EM), Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN). Bextra has been banned from Canada.(28)

Anti-Cholestrol Statin Drugs, Baychol, Lipitor, Crestor, Zocor

Baycol

Baychol is a statin anti-cholesterol drug which was recalled because muscle damage releases muscle debris into the bloodstream which then clogs up the kidneys and causes renal failure.

Lipitor- Pfizer

Lawsuits were filed in New York against Pfizer claiming that Lipitor (atorvastatin) causes memory loss, peripheral neuropathy, fatigue and muscle damage. Lipitor's labelling warns patients to tell their doctor if they suffer any symptoms of muscle pain or weakness.

More Lipitor litigation against Pfizer was filed on September 28, 2005 in Boston by Hagens Berman Sobol Shapiro claiming Pfizer deceived consumers about the benefits of Lipitor through deceptive marketing and advertising activities. Billions of Lipitor profits come from patients who do not benefit from the drug.

Left Image: Charles Pfizer (born 1824 in Ludwigsburg as Karl Pfizer, died October 19, 1906) was a German chemist who immigrated to the United States in the early 1840s and founded the Pfizer Inc. pharmaceutical company in 1849 as Charles Pfizer & Co. Courtesy of Wikipedia.

According to the complaint, Pfizer launched a massive campaign to convince the public that Lipitor is a beneficial treatment for nearly everyone with elevated cholesterol, even though no studies have shown it to be effective for women and those over 65 years of age who do not already have heart disease or diabetes. For more information on lipitor, zocor and all the statin anti-cholesterol drugs, see my previous articles on this topic.(54)(55)

Crestor

Crestor (rosuvastatin) is a statin anti-cholesterol drug similar to the recalled drug Baycol. Compared to other statins, Crestor has the greatest kidney toxicity, causing muscle breakdown products to clog the kidneys. During clinical trials, patients taking the 80 mg dose of Crestor began to show clogging of the kidneys with the muscle debris. Because of this finding, the 80 mg dosage was discontinued.

Psychiatric Drugs Atypical Antipsychotics, SSRI’s etc

Adderall, an amphetamine by Shire markets used for ADHD.(29) On February 9, 2005, Health Canada suspended the sale of ADDERALL used for Attention Deficit Hyperactivity Disorder (ADHD) in children because of 20 reports of sudden death. Fourteen of which occurred in children, and six in adults. There were 12 reports of stroke, two of which occurred in children.

Ritalin

Numerous Ritalin lawsuits against Novartis were filed through the 1990s. Simultaneously, there was a campaign against ADHD medications for children by various interest groups.

Starting in 2000, lawsuits were filed against Novartis for fraud in the marketing and over promotion of Ritalin and Attention Deficit Hyperactivity Disorder. The suits alleged that Novartis was conspiring with the APA (American Psychiatric Association) to increase sales of these lucrative drugs by illegally promoting off label use.

Zyprexa and Seroquel cause Tardive Dyskinesia, diabetes, hyperglycemia, pancreatitis, and ketoacidosis. Eli Lilly has already agreed to pay $1.2 billion to settle 28,500 lawsuits. Secret Zyprexa documents have been disclosed to the public by medical heroes at great personal risk (30)(31)

Dr. Timothy Scott, author of, "America Fooled: The Truth about Antidepressants, Antipsychotics and How We've Been Deceived, reports a 2005 study that found there are approximately 30,000 children under 5 on these atypical anti-psychotic drugs.

Dr. Fred Baughman, author of "The ADHD Fraud: How Psychiatry Makes "Patients" of Normal Children," reports that 10 million of the 50-million school children in the nation are on one or more psychiatric drugs and states: "This is death by psychiatry." (32)(33)(34)(35)

The Children's Hospital of Philadelphia recently found that 19% of children who were newly diagnosed with Type 2 diabetes were being treated with these new atypical anti-psychotic drugs which cause obesity and diabetes (36)(37)(37A)

Some 200 legal actions have been filed against Eli Lilly, Pfizer, and GlaxoSmithKline, the manufacturers of Prozac (fluoxetine), Zoloft (sertraline), and Paxil (paroxetine) to recover for suicides or homicides by patients. The lawsuits claim that the companies knew about, but hid the documents which showed increased risk of akathisia, a form of agitation causing suicide and violence.

Prozac

Payouts by Lilly estimated to be over $50 million to quietly settle more than 30 of those Prozac lawsuits. (40)(41)
Paxil

Paxil causes serious side effects, agitation, violent or suicidal behavior, painful withdrawal and addiction problems. It may cause birth defects in pregnant women. Paxil has been recklessly prescribed to children when it was proven no more effective than a placebo. Both children and adults taking Paxil have demonstrated suicidal tendencies during treatment, while trying to quit and during withdrawal.

For more information on SSRI drug adverse side effects and SSRI induced suicide, see my previous article on this topic.(56)

Strattera

Strattera is used for ADHD in children, teens, and adults, and causes serious liver side effects and jaundice. Strattera may also cause suicidal thoughts in children and teens.

Serzone

Serzone is an anti-depressant which increases the risk of liver failure by 3-4 times.

Acne Drug, Accutane

Accutane (isotretinoin) is Hoffman La Roche’s acne drug, an oral drug for severe nodular acne (the bad type of acne that can lead to scarring). Accutane is a synthetic form of vitamin A designed to dry up oil that clog the pores and cause acne. Accutane can cause depression, psychotic symptoms, and rarely suicide attempts. There have been over 142 suicides involving Accutane since 1982. In October 2001, Congressman Bart Stupak’s son committed suicide while taking Accutane. Accutane also causes severe birth defects and fetal death. Accutane side effects are, Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Birth Defects, Suicide, Psychiatric disorders.

Erectile Dysfunction ED Drugs, Viagra, Levitra, Cialis

Viagra

On May 27, 2005, the FDA reported that Viagra, (by Pfizer) may cause temporary or permanent vision loss, and reported 50 cases of "Viagra blindness". This blindness is due to occlusion of the artery to the eye, causing optic nerve stroke and damage. This severe adverse event affects people with blood vessel problems, like diabetes or hypertension.

Tequin (gatifloxacin), an antibiotic by Bristol-Myers Squibb Co. which causes hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), which can lead to coma or seizure and potentially fatal. Tequin was withdrawn from market in 2006 .

Lariam (mefloquine) causes psychiatric symptoms, anxiety, paranoia, depression, hallucinations and psychotic behavior, even long after Mefloquine has been stopped. Suicidal ideation and suicide have been reported

TROVAN , trovafloxacin On June 9, 1999, FDA issued a public health advisory about risks of liver toxicity from Trovan (trovafloxacin)

Diet Pills Fen-Phen

Fen-phen is a combination of fenfluromine and phentermine. Fen-Phen had been approved for many years as an appetite suppressant in the management of obesity. The trouble with this drug combo is that it has been found to cause heart valve disease. American Home Products Corp. offered $3.75 billion last year to settle lawsuits over its fen-phen diet pills, which it yanked from the market in 1997 over health concerns.

Propulsid is a drug approved for patients with severe heartburn or gastro esophageal reflux. Propulsid can cause irregular or abnormal heart rhythms.

Neurontin A 2004 lawsuit alleges that Parke Davis created an illegal promotional campaign to get more patients to use Neurontin which is approved for epilepsy. Disguised as medical education for the doctors or consulting for the company, the promotional campaign included illegal cash kickbacks to physicians and other sales ploys to pump up sales of Neurontin for non-FDA approved uses.

Thimerosal

Thimerosal is used in vaccines as a preservative. Thimerosal degrades into ethyl mercury, a highly toxic form of mercury which causes neurological disorders(42).

Elidel (pimecrolimus) and Protopic (tacrolimus) are topical creams for eczema, both linked to skin cancer and lymphoma. A black box warning was given 2006.

Latest developments Wyeth v. Levine:

At issue is Wyeth v. Levine, a case expected to be heard late this year. The case is closely watched because the Supreme Court ruled this year that manufacturers of FDA-approved medical devices were shielded from litigation in state courts. The New England Journal Medical Editor, Dr. Jeffrey M. Dariens, is joined by 47 state attorneys general and two former FDA commissioners, David Kestrel and Donald Kennedy in his statement, "Without the discoveries dredged up by plaintiffs' lawyers through liability litigation, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."(57)

If Wyeth wins this case, there will be no more "bad drug drug litigation". Where is the sense of public outrage?

Disclaimer

It is important to discuss any treatment plan with your personal physician. Do not start or stop a treatment, drug, supplement or lifestyle change based on information from this article. Even if a drug is on a ligation, recall or black box list, any decision to start or stop a drug should be made in consultation with your own doctor, who should help you weigh the comparative risks and benefits to arrive at an informed decision. Some of the drugs given black box warnings are in common use because the benefits are felt to outweigh the risks. These are complex issues that require professional advice.

(22) American Association of Oral and Maxillofacial Surgeons Position Paper on Bisphosphonate-Related Osteonecrosis of the Jaws Approved by the Board of Trustees September 25, 2006 “it would appear prudent to consider all patients taking bisphosphonates to be at some risk for ONJ,”

(41) http://en.wikipedia.org/wiki/Eli_Lily
E Lily at Wikipedia, In a trial case of SSRI suicide, Eli Lilly was caught corrupting the judicial process by making a deal with the plaintiff's attorney to throw the case, known as the Fentress Case involved a Kentucky man, Joseph Wesbecker, on Prozac, who went to his workplace and opened fire killing 7 people, and injuring 12 others before turning the gun on himself. The jury returned a 9-to-3 verdict in favor of Lilly. The judge, in the end, took the matter to the Kentucky Supreme Court, which found that "there was a serious lack of candor with the trial court and there may have been deception, bad faith conduct, abuse of judicial process and, perhaps even fraud." The judge later revoked the verdict and instead, recorded the case as settled for a secret amount thought to be huge.

(46) http://www.pharmedout.org/aboutus.htm
PharmedOut is an independent project run by physicians for physicians and other prescribers. Our goals are to: Document and disseminate information about how pharmaceutical companies influence prescribing. Provide access to unbiased information about drugs. Encourage physicians to choose pharma-free CME. PharmedOut is led by a team of physicians and academics and is contributed to by a diverse group. The Principal Investigator is Adriane Fugh-Berman MD and the Project Manager is Alicia M. Bell MS. Pharmed Out Blog

(47) http://www.medicalaccountability.net/index.html
Moira Dolan, MD, Medical Accountability Network provides business healthcare solutions based on principles of integrity in medicine. We consider informed consent as the keystone to responsible health care management. Through advocacy, education and business solutions the M.A.N. seeks to raise the responsibility of all participants affected by medical matters. Medical Accountability Blog

Lawsuits can serve as "a vital deterrent" and protect consumers if drug companies do not disclose risks to the U.S. Food and Drug Administration before it approves medicines for use, the editors of the New England Journal of Medicine said in a friend-of-the-court brief. The FDA "is in no position" to guarantee drug safety, the brief said.

At issue is Wyeth v. Levine, a case expected to be heard late this year.The case is being closely watched because the Supreme Court ruled this year that manufacturers of FDA-approved medical devices were shielded from litigation in state courts.

" the doctors said in a brief filed Thursday. Without the discoveries dredged up by plaintiffs' lawyers through liability litigation, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."

"Even if the FDA is doing the best it can, it simply can't see the future clearly enough to pre-empt manufacturers from litigation," he said. "The (court) system represents one of the key defense mechanisms that individuals have if a manufacturer has not made the risks of a product clear to the public.""The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety,

The medical editor, Dr. Jeffrey M. Dariens, is joined 47 state attorneys general and two former FDA commissioners, David Kestrel and Donald Kennedy, in supporting Levine's position. Kestrel served in the administrations of former President Bill Clinton, a Democrat, and Republican President George H.W. Bush. Kennedy served in Democratic President Jimmy Carter's administration.

The reader is advised to discuss the comments on these pages with his/her personal physicians and to only act upon the advice of his/her personal physician Also note that concerning an answer which appears as an electronically posted question, I am NOT creating a physician -- patient relationship. Although identities will remain confidential as much as possible, as I can not control the media, I can not take responsibility for any breaches of confidentiality that may occur .

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